NDI-101150 + Pembrolizumab for Cancer

Recruiting in Palo Alto (17 mi)

+19 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Nimbus Saturn, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called NDI-101150, alone or with pembrolizumab, in adults with advanced cancers. It aims to find the safest dose and see how well it works. Pembrolizumab helps the immune system attack cancer cells and is used to treat various cancers.

Research Team

Anita Scheuber, MD

Principal Investigator

Nimbus Saturn

Eligibility Criteria

This trial is for adults with advanced solid tumors who have a life expectancy of at least 12 weeks, are willing to undergo tumor biopsies if needed, and have recovered from previous therapies. They should not have had cancer treatment in the last 4 weeks and must be in good physical condition (ECOG status 0-1). People with recent malignancies, severe allergies to monoclonal antibodies, untreated brain cancers, significant heart or lung conditions, or uncontrolled medical issues cannot join.

Inclusion Criteria

My bone marrow, kidney, and liver are functioning well.

My cancer can be measured by scans for the treatment study.

I agree to a tumor biopsy and have advanced cancer with no standard treatment options.

Exclusion Criteria

I do not have any severe uncontrolled health conditions.

I have a brain or spinal cord tumor that hasn't been treated, is spreading, or needs medication.

I have a serious heart condition.

Treatment Details

Interventions

• NDI-101150 (Other)
• Pembrolizumab (Monoclonal Antibodies)

Trial Overview The study aims to find the safest high dose (MTD) and best Phase 2 dose (RP2D) of NDI-101150 alone or combined with pembrolizumab. It will look into how these treatments affect patients' bodies (pharmacokinetics), their action on tumors (pharmacodynamics), safety profiles, and initial effectiveness against solid tumors.

Participant Groups

Group I: NDI-101150-Pembrolizumab (Combination therapy) Experimental Treatment 2 Interventions

Patients in escalation and expansion phase, will receive NDI-101150 capsules orally once daily continuously in 3-week cycles (21 days), along with pembrolizumab via intravenous (IV) infusion at a dose of 200 mg every 3 weeks.

Group II: NDI-101150 (Monotherapy) Experimental Treatment 1 Intervention

Patients in escalation and expansion, will receive NDI-101150 capsules orally once daily continuously in 4-week cycles (28 days).

Who Is Running the Clinical Trial?

Nimbus Saturn, Inc.

Lead Sponsor

Trials

1

Recruited

110+